CN216603189U

CN216603189U - Implant ring body and anchoring system thereof

Info

Publication number: CN216603189U
Application number: CN202120894332.4U
Authority: CN
Inventors: 李建文; 杨亮; 李峰; 李嘉智
Original assignee: Shanghai Yuban Medical Technology Co ltd
Current assignee: Shanghai Yuban Medical Technology Co ltd
Priority date: 2021-04-27
Filing date: 2021-04-27
Publication date: 2022-05-27
Anticipated expiration: 2031-04-27

Abstract

The invention belongs to the field of interventional medical instruments, and particularly belongs to an implant ring body and an anchoring system thereof. The implantation ring body comprises a ring-shaped main body and a plurality of anchoring nails, wherein the ring-shaped main body is fixedly arranged on human tissues through the anchoring nails; the annular body is configured as a hollow tubular, and the anchor includes an upper portion and a lower portion that clamp the annular body and the body tissue. An anchoring system comprises a conveying sheath and a dilator, wherein the conveying sheath is a tubular structure with a through center, the end part of the dilator is provided with a conical structure, and the dilator is arranged in the cavity of the conveying sheath. The invention provides an implant ring body and an anchoring system thereof, which change a sharp anchor structure in the prior art, adopt a double-layer clamped anchor structure to anchor the implant ring body, and adopt a non-destructive mode to anchor the implant ring body, thereby avoiding further stress injury to the myocardium and coronary artery caused by the implant ring body in the using process.

Description

Implant ring body and anchoring system thereof

Technical Field

The invention belongs to the field of interventional medical instruments, and particularly belongs to an implant ring body and an anchoring system thereof.

Background

Mitral Regurgitation (MR) in mitral valve disease is a serious concern for patients, and normally the mitral valve in the human heart acts as a hemostatic valve to prevent the backflow of oxygen-enriched blood from the lungs into the left atrium, and MR is generated once the mitral valve is improperly closed or misaligned, which can significantly reduce the pumping efficiency of the heart and even cause heart failure. Mitral regurgitation is divided into both degenerative and functional, and the poor results and ambiguous benefits of surgical mitral valvuloplasty in the context of MR have encouraged the search for alternative, innovative, catheter and minimally invasive solutions, such as percutaneous margin-to-margin repair, indirect annuloplasty, direct annuloplasty, and transcatheter mitral valve replacement.

The Cardioband system (Edwards Lifescience, Irvine, USA) is a percutaneously adjustable surgical direct annuloplasty device. The device is implanted on the beating annulus of the heart through the interatrial septum by transfemoral approach, which allows real-time reduction of the size of the mitral annulus and improved mitral leaflet coaptation. Up to now, Cardioband has been implanted in more than 400 patients with functional mitral regurgitation. The Cardioband Delivery System (CDS) is a sutureless band based on annuloplasty, largely replicating the surgical annuloplasty technique and is composed of three parts:

(1) an adjustable bend delivery system for implantation;

(2) the anchoring driver can realize one-to-one torque transmission for the implantation of the anchoring nail;

(3) an annulus sizing mechanism that provides uniform gradual tightening.

Cardioband uses a delivery sheath to deliver a plurality of anchor screws and precisely screw into specific locations to secure the annuloplasty ring around the valve. Cardioband has been reported to produce adverse events such as anchor sloughing, coronary damage, etc. during the initial period of implantation. Therefore, the invention provides an anchor and a delivery system made of memory alloy materials.

Disclosure of Invention

The implantation ring body comprises a ring-shaped main body and a plurality of anchoring nails, wherein the ring-shaped main body is fixedly arranged on human tissues through the anchoring nails; the annular body is configured as a hollow tubular, and the anchor includes an upper portion and a lower portion that clamp the annular body and the body tissue.

As a preferred technical solution, the anchor further includes a connecting rod, the upper portion and the lower portion are fixedly connected through the connecting rod, the upper portion is fixedly connected to the top end of the connecting rod, and the lower portion is fixedly connected to the bottom end of the connecting rod.

As a preferable technical scheme, the upper part is provided with a plurality of independent structures which expand from the top end of the connecting rod to the periphery; the lower part is arranged into a plurality of independent structures which expand from the bottom end of the connecting rod to the periphery.

As a preferred technical solution, the annular main body is made of a polymer material, and the anchor is made of a mesh-shaped metal material; preferably, the anchor is one of reticular nickel-titanium alloy, stainless steel, cobalt-chromium alloy and titanium alloy.

As a preferable mode, the upper portion is disposed inside the cavity of the annular body, the connecting rod passes through a sidewall of the annular body, and the lower portion is disposed outside the sidewall of the annular body.

An anchoring system based on any one of the implantation ring bodies comprises a conveying sheath and a dilator, wherein the conveying sheath is a tubular structure with a through center, the end part of the dilator is provided with a conical structure, and the dilator is arranged in the cavity of the conveying sheath.

As a preferred technical scheme, the anchor further comprises a pull ring, and the pull ring is arranged at the top end of the anchor.

As a preferred technical scheme, the conveying sheath further comprises a push rod, wherein the push rod is a hollow rod, and the push rod is arranged in a cavity of the conveying sheath.

As a preferable technical scheme, the pull-type push rod further comprises a pull rope, the pull rope penetrates through the pull ring, and the pull rope is arranged in a cavity of the push rod.

As a preferred aspect, the upper and lower portions comprise a first configuration and a second configuration, the upper portion being in the first configuration when the upper portion is positioned within the delivery sheath lumen; when the upper portion is detached from the delivery sheath, the upper portion is in a second configuration; when the lower portion is within the delivery sheath lumen, the lower portion is in a first configuration; when the lower portion is detached from the delivery sheath, the lower portion is in a second configuration.

Has the advantages that:

(1) the invention provides an implant ring body and an anchoring system thereof, which change a sharp anchor structure in the prior art, adopt a double-layer clamped anchor structure to anchor the implant ring body, and adopt a non-destructive mode to anchor the implant ring body, thereby avoiding further stress injury to the myocardium and coronary artery caused by the implant ring body in the using process.

(2) The invention provides an implanted ring body and an anchoring system thereof, which are used for reducing the interval of mitral valves, and provide anchoring force for fixing the implanted ring body to muscle tissues by means of net-shaped memory wires, thereby improving the firmness. Compare in the rotatory nail structure of effectual metal of anchoring among the prior art, the mode of upper and lower portion centre gripping does not have the risk of derotation, can keep the anchor to stay on body tissue for a long time and can not drop.

(3) In the anchoring system, the anchoring nail is completely unfolded and tightly attached to a target position through the mutual matching of the rigid push rod, the flexible pull rope and the pull ring, and the implanted ring body and body tissues are tightly clamped through the matching of the upper part and the lower part, so that the anchoring stability is ensured.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic view of an implant ring body according to the present invention;

FIG. 2 is a schematic structural view of an implant ring and anchoring system thereof according to the present invention during implantation;

FIG. 3 is a schematic structural view of an implant ring and anchoring system thereof according to the present invention during implantation;

FIG. 4 is a schematic structural view of an implant ring and anchoring system thereof according to the present invention during implantation;

FIG. 5 is a schematic structural view of an implant ring and anchoring system thereof according to the present invention during implantation;

wherein, 1-annular main body, 2-anchor, 21-upper part, 22-lower part, 23-connecting rod, 3-conveying sheath, 4-dilator, 5-pull ring, 6-push rod, 7-pull rope and 8-human tissue.

Detailed Description

The invention will be further understood by reference to the following detailed description of preferred embodiments of the invention and the examples included therein.

When describing embodiments of the present application, the use of "preferred," "preferably," "more preferred," and the like, is meant to refer to embodiments of the invention that may provide certain benefits, under certain circumstances. However, other embodiments may be preferred, under the same or other circumstances. In addition, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, nor is it intended to exclude other embodiments from the scope of the invention.

In this document, relational terms such as first, second, and the like may be used solely to distinguish one entity from another entity without necessarily requiring or implying any actual such relationship or order between such entities. Furthermore, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a component, apparatus, or device that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such component, apparatus, or device.

When a component, element, or layer is referred to as being "on," "bonded to," "connected to," or "coupled to" another element or layer, it may be directly on, bonded to, connected to, or coupled to the other element, or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being "directly on," "directly coupled to," "directly connected to" or "directly coupled to" another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a similar manner (e.g., "between … …" versus "directly between … …," "adjacent" versus "directly adjacent," etc.).

The implantation ring body shown in fig. 1 comprises a ring-shaped main body 1 and a plurality of anchor bolts 2, wherein the ring-shaped main body 1 is fixedly arranged on human tissues through the plurality of anchor bolts 2; the annular body 1 is provided in a hollow tubular shape, and the anchor stud 2 comprises an upper portion 21 and a lower portion 22, wherein the upper portion 21 and the lower portion 22 clamp the annular body 1 and human tissue.

The anchor bolt 2 further comprises a connecting rod 23, the upper portion 21 and the lower portion 22 are fixedly connected through the connecting rod 23, the upper portion 21 is fixedly connected to the top end of the connecting rod 23, and the lower portion 22 is fixedly connected to the bottom end of the connecting rod 23.

The upper part 21 is provided with a plurality of independent structures which expand from the top end of the connecting rod 23 to the periphery; the lower portion 22 is provided as a plurality of independent structures spreading from the bottom end of the connecting rod 23 to the periphery.

The annular main body 1 is made of high polymer materials, and the anchor 2 is made of reticular nickel-titanium alloy materials.

The upper portion 21 is disposed inside the cavity of the ring body 1, the connection rod 23 passes through the sidewall of the ring body 1, and the lower portion 22 is disposed outside the sidewall of the ring body 1.

As shown in figures 2-5, the anchoring system based on the implanted ring body comprises a conveying sheath 3 and an expander 4, wherein the conveying sheath 3 is a tubular structure with a through center, the end part of the expander 4 is provided with a conical structure, and the expander 4 is arranged in the cavity of the conveying sheath 3.

Still include pull ring 5, pull ring 5 set up in the top of anchor nail 2.

The conveying sheath is characterized by further comprising a push rod 6, wherein the push rod 6 is a hollow rod, and the push rod 6 is arranged in a cavity of the conveying sheath 3.

The pull ring is characterized by further comprising a pull rope 7, wherein the pull rope 7 penetrates through the pull ring 5, and the pull rope 7 is arranged in a cavity of the push rod 6.

Preferably, the pull cord 7 is a polymer thread.

Said upper portion 21 and lower portion 22 comprise a first configuration and a second configuration, said upper portion 21 being in the first configuration when said upper portion 21 is located within the lumen of said delivery sheath 3; when the upper portion 21 is detached from the delivery sheath 3, the upper portion 21 is in a second configuration; when the lower portion 22 is located within the lumen of the delivery sheath 3, the lower portion 22 is in a first configuration; when the lower portion 22 is detached from the delivery sheath 3, the lower portion 22 is in the second configuration.

The first configuration is a retraction configuration, the expanded independent structures of the upper part 21 and the lower part 22 are retracted to be close to the connecting rod 23 under the blocking effect of the delivery sheath 3, and in the first configuration, the anchor 2 can enter a target position in vivo from the outside of the body through a medical catheter; the second configuration is a deployment configuration, the expanded independent components of the upper part 21 and the lower part 22 are deployed outwards, and in the second configuration, the anchor nail 2 tightly clamps the implantation ring body and the human tissue together through the matching of the upper part 21 and the lower part 22, so as to achieve the purpose of stable anchoring.

The implementation principle is as follows:

firstly, the high molecular ring body is delivered into human tissue by a delivery system, such as a mitral valve posterior leaflet ring, the distal ends of a delivery sheath and a dilator reach the inner cavity of the ring body through the delivery system and the inner channel of the ring body, the delivery sheath and the dilator which are positioned outside the body are pushed, the non-obstruction delivery channel is formed by piercing the high molecular ring and the tissue surface by the tapered tip part at the distal end of the dilator, the dilator is withdrawn, the anchor is folded (the anchor net is composed of 3 petals on the circumference and can be plugged into the delivery sheath after being folded) and delivered into the inner cavity of the delivery sheath, the anchor is pushed to the junction of the high molecular ring and the valve annulus tissue by a delivery rod, the anchor is pushed to push slowly until the lower anchor pushes out the delivery sheath and punctures into muscle tissue. The pull rope is a polymer thread, passes through a pull ring at the top of the upper anchoring nail, and is used together with the push rod to play a role in controlling the releasing position of the anchoring nail. After the lower anchoring nail is released, the pulling rope is used for pulling the anchoring nail to the near end, the upper anchoring nail is positioned at the upper end of the polymer ring, and the conveying sheath is withdrawn at the moment to release the upper anchoring nail, so that the aim of fixing the polymer ring on the muscle tissue is fulfilled.

The foregoing examples are merely illustrative and serve to explain some of the features of the methods described herein. The appended claims are intended to claim as broad a scope as is contemplated, and the examples presented herein are merely illustrative of selected implementations in accordance with all possible combinations of examples. Accordingly, it is applicants' intention that the appended claims are not to be limited by the choice of examples illustrating features of the present application. Also, where numerical ranges are used in the claims, subranges therein are included, and variations in these ranges are also to be construed as possible being covered by the appended claims.

Claims

1. The implantation ring body is characterized by comprising a ring-shaped body (1) and a plurality of anchor bolts (2), wherein the ring-shaped body (1) is arranged in a hollow tubular shape, the anchor bolts (2) comprise an upper part (21) and a lower part (22), and the upper part (21) and the lower part (22) clamp the ring-shaped body (1) and human tissues.

2. The implant ring according to claim 1, characterized in that the anchor (2) further comprises a connecting rod (23), the upper portion (21) and the lower portion (22) being fixedly connected by the connecting rod (23), the upper portion (21) being fixedly connected to a top end of the connecting rod (23), the lower portion (22) being fixedly connected to a bottom end of the connecting rod (23).

3. The implant ring according to claim 2, characterized in that said upper portion (21) is provided as a number of independent structures extending from the top end of said connecting rod (23) towards the periphery; the lower part (22) is arranged into a plurality of independent structures which expand from the bottom end of the connecting rod (23) to the periphery.

4. The implant ring body according to claim 1, characterized in that the ring-shaped body (1) is a polymer material and the anchor stud (2) is a mesh-like metal material.

5. The implant ring body of claim 4, wherein the anchor is one of a nickel titanium alloy, a stainless steel, a cobalt nickel alloy, and a titanium alloy.

6. Implant ring according to claim 2, characterized in that said upper portion (21) is arranged inside the cavity of said ring-shaped body (1), said connecting rod (23) passing through the lateral wall of said ring-shaped body (1), said lower portion (22) being arranged outside the lateral wall of said ring-shaped body (1).

7. An anchoring system based on an implantation ring body of any one of claims 1 to 5, comprising a delivery sheath (3) and a dilator (4), wherein the delivery sheath (3) is a tubular structure with a through center, the end of the dilator (4) is provided with a conical structure, and the dilator (4) is arranged in a cavity of the delivery sheath (3).

8. The anchoring system for implantation of a ring according to claim 7, further comprising a pull ring (5), said pull ring (5) being provided at the tip of said anchor (2).

9. Anchoring system to an implant ring according to claim 8, characterized in that it further comprises a push rod (6), said push rod (6) being a hollow rod, said push rod (6) being arranged inside the cavity of said delivery sheath (3).

10. The anchoring system of the implant ring according to claim 9, further comprising a pull cord (7), said pull cord (7) passing through said pull ring (5), said pull cord (7) being disposed within a cavity of said push rod (6).

11. Anchoring system of the implant ring according to claim 7, characterized in that said upper (21) and lower (22) portions comprise a first configuration and a second configuration, said upper portion (21) being in the first configuration when said upper portion (21) is located in the cavity of said delivery sheath (3); when the upper portion (21) is detached from the delivery sheath (3), the upper portion (21) is in a second configuration; when the lower portion (22) is located within the lumen of the delivery sheath (3), the lower portion (22) is in a first configuration; when the lower portion (22) is detached from the delivery sheath (3), the lower portion (22) is in a second configuration.